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Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia (FREESARC)

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self-rehabilitation program and protein supplement
Sponsored by
Institut Mutualiste Montsouris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 70 or older
  • Non-institutionnalised patients
  • Patients suffering of sarcopenia during hospitalisation (assessed by the Short Physical Performance Battery, Bio-Impedance analysis and griptest)
  • Patients hospitalised in the service of Internal Medicine of Institut Mutualiste Montsouris
  • Patients returning at home after hospitalisation
  • Patients who gave their written consent
  • Patients who benefits from a social security coverage

Exclusion Criteria:

  • Patients suffering from a severe medical condition not allowing them to follow a physical exercise program
  • Palliative care patients
  • Patients without the musculo-squelettic capacity to follow the program : 4/4 on seated postural stability scale ; no motor deficit on lower limb muscular testing ; quadricipital locking when standing
  • Patients with severe cognitive disorders (according to MMSE score adapted to socio-cultural level and age)
  • Patients who live more than 150 km away
  • Patients following specific physiotherapy

Sites / Locations

  • Institut Mutualiste MontsourisRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1: Self-rehabilitation arm

Arm Description

Self-rehabilitation arm

Outcomes

Primary Outcome Measures

Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
Measured from program adherence using a patient notebook
Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
Measured from patient satisfaction using a satisfaction scale
Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
Measured from medical time required by phone call

Secondary Outcome Measures

Muscular status evaluation
Change in muscle mass measured with Bio-Impedance analysis
Muscular status evaluation
Performance in muscle mass measured with Short Physical Performance Battery
Muscular status evaluation
Force in muscle mass measured with Grip test
Autonomy degree evaluation
Change in autonomy measured with Barthel Index
Quality of life evaluation
Change in quality of life measured with Médical Outcomes Study Short Form 36

Full Information

First Posted
January 21, 2019
Last Updated
February 6, 2019
Sponsor
Institut Mutualiste Montsouris
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1. Study Identification

Unique Protocol Identification Number
NCT03834103
Brief Title
Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia
Acronym
FREESARC
Official Title
Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Loss of autonomy among elderly during and after hospitalisation is a well-known problem. Patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not to recover their previous autonomy. Studies have shown that physical exercise, especially resistance exercises, is the most efficient known treatment of sarcopenia. Several institution-based rehabilitation programs had been implemented in this purpose. On the other hand, some studies have shown that home-based self-rehabilitation can be as efficient as institution-based rehabilitation, for example in stroke, cardiac failure and COPD rehabilitation. The investigators propose to set up a home-based self-rehabilitation program to fight against sarcopenia and hence increasing autonomy among elderly. This study aimed to establish the feasibility of such a program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Self-rehabilitation arm
Arm Type
Other
Arm Description
Self-rehabilitation arm
Intervention Type
Behavioral
Intervention Name(s)
Self-rehabilitation program and protein supplement
Intervention Description
Participants follow a home-based self-rehabilitation program consisting of the realisation of a set of physical exercises using an elastic band. The exercises have to be performed 3 times a week, and are associated with a protein supplementation. The rehabilitation follow-up by the physician is planned once a week, by phone, and with face-to-face appointments at inclusion, 6 weeks and 3 months follow-up.
Primary Outcome Measure Information:
Title
Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
Description
Measured from program adherence using a patient notebook
Time Frame
3 months
Title
Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
Description
Measured from patient satisfaction using a satisfaction scale
Time Frame
3 months
Title
Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients
Description
Measured from medical time required by phone call
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Muscular status evaluation
Description
Change in muscle mass measured with Bio-Impedance analysis
Time Frame
3 months
Title
Muscular status evaluation
Description
Performance in muscle mass measured with Short Physical Performance Battery
Time Frame
3 months
Title
Muscular status evaluation
Description
Force in muscle mass measured with Grip test
Time Frame
3 months
Title
Autonomy degree evaluation
Description
Change in autonomy measured with Barthel Index
Time Frame
3 months
Title
Quality of life evaluation
Description
Change in quality of life measured with Médical Outcomes Study Short Form 36
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 70 or older Non-institutionnalised patients Patients suffering of sarcopenia during hospitalisation (assessed by the Short Physical Performance Battery, Bio-Impedance analysis and griptest) Patients hospitalised in the service of Internal Medicine of Institut Mutualiste Montsouris Patients returning at home after hospitalisation Patients who gave their written consent Patients who benefits from a social security coverage Exclusion Criteria: Patients suffering from a severe medical condition not allowing them to follow a physical exercise program Palliative care patients Patients without the musculo-squelettic capacity to follow the program : 4/4 on seated postural stability scale ; no motor deficit on lower limb muscular testing ; quadricipital locking when standing Patients with severe cognitive disorders (according to MMSE score adapted to socio-cultural level and age) Patients who live more than 150 km away Patients following specific physiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle SAURET
Phone
+33 1 56 61 67 05
Email
isabelle.sauret@imm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline RIX
Phone
+33 1 56 61 63 71
Email
caroline.rix@imm.fr
Facility Information:
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle SAURET
Phone
+ 33 1 56 61 67 05
Email
isabelle.sauret@imm.fr
First Name & Middle Initial & Last Name & Degree
Caroline RIX
Phone
+ 33 1 56 61 63 71
Email
caroline.rix@imm.fr
First Name & Middle Initial & Last Name & Degree
Martine GAYRAUD LARMIGNAT, MD

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia

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